Gunther TulipRecalls & reported problems across all models

We found 5 models of Gunther Tulip by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 807 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2014 and Apr 11, 2026 — classified as 8 deaths, 517 injuries, 280 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (259 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Gunther Tulip problems

Gunther Tulip models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Gunther Tulip G33016

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  3 deaths348 reports
• Gunther Tulip G33017

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  3 deaths286 reports
• Gunther Tulip G13287

  Device, percutaneous retrieval
  1 death98 reports
• Gunther Tulip G21360

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  1 death69 reports
• Gunther Tulip G13287

  Device, percutaneous retrieval
  6 reports

Recent Gunther Tulip adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Difficult to Fold, Unfold or Collapse; Detachment of Device or Device Component

  AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED COOK CELECT FILTER, THE ¿Y-CONNECTOR¿ SEPARATED FROM A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S SNARE. THE FILTER HAD BEEN IN PLACE FOR TWELVE YEARS. PER THE REPORTER, THE HOOK OF THE FILTER WAS EASILY CAPTURED WITH THE SNARE. A MODERATE AMOUNT OF FORCE WAS NEEDED TO ADVANCE THE SHEATHS OVER THE FILTER IN ORDER TO COLLAPSE IT, AND THE ¿CONNECTION BETWEEN THE INNER AND OUTER SHEATH BROKE.¿ THE OUTER SHEATH ACCORDIONED OUTSIDE OF THE ACCESS SITE/BODY, AND THE ¿Y-CONNECTOR¿ BROKE FROM THE SNARE. THE COMPLAINT DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE RETRIEVAL PROCEDURE WAS ABORTED AND RESCHEDULED TO BE COMPLETED ANOTHER DAY. A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847538 ↗
• MalfunctionMar 12, 2026Difficult to Fold, Unfold or Collapse; Material Split, Cut or Torn

  AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH CRACKED. PER THE REPORTER, THE PROCEDURE WENT WELL AND WAS SUCCESSFUL. UPON REMOVAL OF THE DEVICE FROM THE PATIENT, THE USER NOTED THAT THE SHEATH WAS RIPPED/CRACKED. REPORTEDLY, MEDICAL STAFF SPECULATED THAT ONE OF THE FILTER LEGS RIPPED THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582121 ↗
• MalfunctionJan 7, 2026Component Incompatible; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995762 ↗
• MalfunctionAug 18, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE LOOP SEPARATED FROM THE SHAFT AS THE USER ATTEMPTED TO PULL THE FILTER BACK INTO THE GUIDE. PER THE REPORTER, THE RETRIEVAL CASE WAS DIFFICULT, AS THE FILTER WAS SLIGHTLY ANGLED AND ONE LEG WAS POSSIBLY EMBEDDED DEEP INTO THE CAVAL WALL. THE PATIENT IS REPORTEDLY "FINE". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829946 ↗
• InjuryAug 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN FILTER, THE SNARES OF TWO GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SETS BROKE OFF INSIDE THE PATIENT (REPORTED UNDER PATIENT IDENTIFIERS (B)(6)). PER THE REPORTER, THE PHYSICIAN WAS BEING TOO AGGRESSIVE DURING RETRIEVAL ATTEMPTS, WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE DEVICES BREAKING. ONE SNARE WAS SUCCESSFULLY RETRIEVED, AND THE OTHER SNARE FRAGMENT REMAINED IN THE PATIENT, LIKELY HOOKED WITHIN THE FILTER. IT IS UNKNOWN HOW THE RETRIEVED SNARE WAS RECOVERED. ONE OF THE RETRIEVAL SETS¿ BLUE OUTER SHEATHS ALSO SEPARATED FROM THE WHITE HUB; HOWEVER, IT IS UNKNOWN IF THE HUB SEPARATED BEFORE OR AFTER THE SNARE BROKE, AND IT IS UNKNOWN WHICH SET WAS INVOLVED. THE PROCEDURE WAS ABORTED. ALTHOUGH IT IS UNKNOWN WHICH SNARE FRAGMENT REMAINS IN THE PATIENT, THE SERIOUS INJURY WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6) (SUBJECT OF THIS REPORT).

  Patient problems: Foreign Body In Patient

  MAUDE report 22786169 ↗
• MalfunctionMar 14, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING A FILTER RETRIEVAL PROCEDURE, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S WIRE UNRAVELED WHILE OBTAINING ACCESS IN THE INTERNAL JUGULAR VEIN. ACCESS WAS REPORTEDLY DIFFICULT, AS THE VEIN/ACCESS SITE HAD BEEN USED FOR PREVIOUS INTERVENTIONS. THE USER CONTINUED TO USE THE WIRE, DESPITE IT UNRAVELING. THE UNKNOWN FILTER WAS SUCCESSFULLY RETRIEVED AS INTENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606878 ↗
• MalfunctionFeb 26, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  INFORMATION WAS AVAILABLE BUT INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. THE DEVICE WAS USED TO RETRIEVE ANOTHER MANUFACTURER¿S INFERIOR VENA CAVA FILTER THAT WAS PLACED (B)(6) 2024. THE DEVICE APPEARED NORMAL DURING PREPARATION. THERE WAS NO DIFFICULTY ADVANCING, REACHING, OR CAPTURING THE FILTER. BOTH THE BLACK AND BLUE SHEATHS REPORTEDLY RIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471685 ↗
• DeathAug 23, 2024Difficult to Remove; Obstruction of Flow; Structural Problem; Difficult to Remove; Obstruction of Flow; Structural Problem

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010 TO PREVENT BLOOD CLOTS. THE FOLLOWING IS ALLEGED: DEATH, STROKE, VENA CAVA AND ORGAN PERFORATION, BLOOD CLOTS, AND DEVICE IS UNABLE TO BE RETRIEVED. IT IS NOTED AND FURTHER ALLEGED, THE PATIENT EXPERIENCED POOR GENERAL HEALTH DUE TO THE FILTER. APPROXIMATELY 11 YEARS AND 3 MONTHS AFTER RECEIVING THE FILTER IMPLANT, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN AND THE IMAGING FROM THIS SCAN SHOWED THAT THE LEGS OF THE PATIENT'S FILTER HAD PENETRATED THE IVC. THE SCAN ALSO SHOWED THAT THE FILTER LEGS HAD "GONE INTO" THE PATIENT'S PANCREAS, DUODENUM, AND WERE ALSO NEAR THE RENAL VEIN. THE PATIENT EXPIRED ABOUT A MONTH AFTER THE AFOREMENTIONED CT SCAN. THE DEATH CERTIFICATE LISTS INTRACEREBRAL HEMORRHAGE, CHRONIC ANTICOAGULATION, AND DEEP VENOUS THROMBOSIS (DVT) AS THE CAUSES OF DEATH. WRONGFUL DEATH IS ALLEGED BY THE PATIENT'S ESTATE. PER THE DEATH CERTIFICATE: CAUSE OF DEATH: INTRACEREBRAL HEMORRHAGE; CHRONIC ANTICOAGULATION; DEEP VENOUS THROMBOSIS. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH: TRAUMATIC BRAIN INJURY; OSTEOMYELITIS.

  Patient problems: Internal Organ Perforation; Perforation of Vessels; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 20051069 ↗
• InjuryMar 18, 2024Obstruction of Flow; Structural Problem; Unintended Movement; Obstruction of Flow; Structural Problem; Unintended Movement

  PATIENT ALLEGEDLY RECEIVED THE TULIP FILTER ON (B)(6) 2014 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO BARIATRIC SURGERY. PATIENT IS ALLEGING DEVICE MIGRATION, VENA CAVA AND ORGAN PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "GROIN PAIN, BACK PAIN, ABDOMINAL & CHEST PAIN. I ALSO HAVE DIFFICULTY WALKING (LIMP) AND CANNOT STAND. I HAVE SHARP THROBBING PAIN IN MY CHEST AND I AM ON LIFE-LONG ANTICOAGULATION WHICH PREVENTS ME FROM MAINTAINING A HEALTHY LIFESTYLE", "CANNOT RIDE A BICYCLE, CURRENTLY SWIM". ADDITIONALLY, PATIENT ALLEGES TWO DEEP VEIN THROMBOSIS AFTER FILTER IMPLANT AND, ANXIETY. PER A REPORT FROM COMPUTED TOMOGRAPHY (CT) 2: "COOK GUNTHER TULIP FILTER PLACED (B)(6) 2014. CAVAL PERFORATION: YES. 4:30 O'CLOCK 3.9 MM GRADE 4 EXTENDING INTO THE L4 VERTEBRAL BODY. TILT: NO. MIGRATION: NO. PERTINENT NEGATIVES: NONE. ADDITIONAL FINDINGS: NONE". PER A REPORT FROM CT: "ACUTE DEEP VENOUS THROMBOSIS BILATERAL COMMON FEMORAL VEINS SHOWN BY ULTRASOUND NOVEMBER 23". "IMPRESSION: 1. NONOCCLUSIVE THROMBUS IN RIGHT COMMON FEMORAL VEIN. OCCLUSIVE THROMBUS LEFT COMMON FEMORAL AND EXTERNAL AND COMMON ILIAC VEIN NOT EXCLUDED, IVC THROMBUS NOT EXCLUDED, BUT TECHNIQUE NOT OPTIMIZED FO

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Anxiety; Chest Pain; Internal Organ Perforation; Pain; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 18924516 ↗
• InjuryMar 18, 2024Structural Problem; Device Tipped Over; Unintended Movement; Structural Problem; Device Tipped Over; Unintended Movement

  UPDATE 21FEB2024: PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO ACUTE PULMONARY EMBOLISM (PE). PER A REPORT FROM COMPUTED TOMOGRAPHY (CT): "CAVAL PERFORATION: YES. GRADE 4 PERFORATION OF 12 O'CLOCK STRUT INTO DUODENUM. GRADE 3 PERFORATION OF 6 O'CLOCK STRUT TO ABUT L3 VERTEBRAL BODY. MULTIPLE GRADE 1 PERFORATIONS. TILT: YES. NO SUBSTANTIAL CORONAL TILT. 10.79 DEGREES OF SAGITTAL TILT. APEX OF FILTER TOUCHES ANTERIOR WALL OF IVC. MIGRATION: YES. APEX OF FILTER 0.9 CM ABOVE THE LEFT RENAL VEIN CONFLUENCE. PERTINENT NEGATIVES: NO FRACTURE OR MISSING STRUTS SEEN. NO IVC STENOSIS. ADDITIONAL FINDINGS: NO".

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 18922937 ↗
• InjuryJan 25, 2024Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component

  PATIENT ALLEGEDLY RECEIVED A GUNTHER-TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO A HISTORY OF PULMONARY EMBOLISM (PE) AND INABILITY TO TAKE ANTICOAGULANTS. PATIENT IS ALLEGING DEVICE TILT, VENA CAVA AND ORGAN PERFORATION (WITH TINES ABUTTING THE ABDOMINAL AORTA AND THE PSOAS MUSCLE), DEVICE FRACTURE, UNABLE TO BE RETRIEVED, AND EMBEDMENT. IT IS ALLEGED THE PATIENT UNDERWENT TWO UNSUCCESSFUL PERCUTANEOUS FILTER RETRIEVAL ATTEMPTS ((B)(6) 2022) AND A FINAL SUCCESSFUL PERCUTANEOUS RETRIEVAL ((B)(6) 2022) WITH TWO FRACTURED TINES REMAINING IN PATIENT. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING PAIN AND DISTRESS RESTRICTING THE ABILITY TO ENGAGE IN ACTIVITIES OF DAILY LIVING AS WELL AS USE OF APPROXIMATELY "20% OF MY HANDS MY BACK", PATIENT CANNOT GET UP OR DOWN; "THEY BROKE THE HOOK OF FILTER OFF IN MY KIDNEY AND CAN NEVER GET IT OUT". "I CANT LIFT, HOLD ANYTHING W/HANDS WEAK". PER A CT ABDOMEN/PELVIS: "AN IVC FILTER IS NOTED WITHIN THE INFERIOR VENA CAVA. THE IVC FILTER EXTENDS STRUTS EXTENT BEYOND THE IVC WALL. ONE PRONG/STRUT ABUTS THE AORTA. ANOTHER ABUTS THE PSOAS MUSCLE. THERE IS EXTENSION OF THE STRUTS BEYOND THE IVC WALL O

  Patient problems: Device Embedded In Tissue or Plaque; Distress; Internal Organ Perforation; Muscle Weakness/Atrophy; Pain; Perforation of Vessels; Stenosis

  MAUDE report 18580588 ↗
• InjuryOct 10, 2023Structural Problem; Structural Problem

  PATIENT ALLEGEDLY RECEIVED A COOK GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2015 VIA RIGHT COMMON FEMORAL VEIN DUE TO TRAUMA. PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION. PER A REPORT OF COMPUTED TOMOGRAPHY (CT) 1 DATED 30AUG2021, "IVC STENOSIS: NO. FILTER POSITION: BELOW THE RENAL VEINS. FILTER MIGRATION: NONE. FILTER FRACTURE/BENDING: NO. FILTER TILT: NO. FILTER PENETRATION: YES. OTHER FINDINGS: YES. IMPRESSIONS: THE FILTER IS NOT TILTED BUT THE CONE OF THE FILTER IS AGAINST THE ANTERIOR WALL OF THE IVC. AXIAL IMAGE 34. THE ANTERIOR STRUT PENETRATES 8 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM. SAGITTAL IMAGE 71. THE LEFT STRUT PENETRATES 5 MM THROUGH THE IVC WALL. CORONAL IMAGE 70. THE POSTERIOR STRUT PENETRATES 9 MM THROUGH THE IVC WALL. SAGITTAL IMAGE 72. THE RIGHT STRUT PENETRATES 6MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM. CORONAL IMAGE 71."

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 17905816 ↗
• InjuryAug 22, 2023Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT IN (B)(6) 2012 VIA THE UNSPECIFIED FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT). THE PATIENT ALLEGES VENA CAVA PERFORATION AND TILT. THE PATIENT FURTHER ALLEGES 4 PRONGS PERFORATE THE INFERIOR VENA CAVA, MAXIMUM DISTANCE OF PERFORATION IS 3.63 MM, 4.72-DEGREE TILT SUPERIOR LEFT TO INFERIOR RIGHT, LIMITED ACTIVITY, PAIN, INTERNAL BLEEDING, SWELLING, CLOTTING, SCARRING, AND DEFECTIVE FOREIGN OBJECT IN THE BODY PROVIDING REDUCED OR NON-EXISTENT BENEFIT. ON (B)(6) 2019, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿POSITIVE FOR CAVAL PERFORATION. SUPERIOR EXTENT OF IVC FILTER L3 VERTEBRAL BODY. INFERIOR EXTENT L4 VERTEBRAL BODY. A TOTAL OF 4 PRONGS HAVE PERFORATED THROUGH IVC. MAXIMUM DISTANCE PRONGS PERFORATED THROUGH IVC 3.63 MM. 4.72 DEGREE TILT SUPERIOR LEFT TO INFERIOR RIGHT.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Perforation of Vessels; Scar Tissue; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 17596772 ↗
• MalfunctionJul 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT ALLEGEDLY RECEIVED TWO GUNTHER TULIP FILTERS ON (B)(6) 2014 DUE TO DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES CHEST/BACK PAIN, IMPAIRED COGNITIVE FUNCTION, LIMITED MOBILITY, SHORTNESS OF BREATH, NUMBNESS OF EXTREMITIES, AND PAIN.

  Patient problems: Chest Pain; Cognitive Changes; Dyspnea; Numbness; Pain

  MAUDE report 17415964 ↗
• InjuryJul 25, 2023Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6)2011 VIA THE RIGHT INTERNAL JUGULAR VEIN. THE PATIENT ALLEGES ORGAN PERFORATION.

  Patient problems: Internal Organ Perforation; Pain; Perforation of Vessels

  MAUDE report 17391796 ↗

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